Development of a novel UPLC approach to co-prediction of four active compounds in a multi-component pharmaceutical preparation

IF 2.8 3区医学 Q2 BIOCHEMICAL RESEARCH METHODS Journal of Chromatography B Pub Date : 2024-06-01 Epub Date: 2024-05-18 DOI:10.1016/j.jchromb.2024.124159

Özgür Üstündağ , Asiye Üçer , Erdal Dinç

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Abstract

In this work, a new ultra-performance liquid chromatography method based on photodiode array detection (UPLC-PDA) was first developed for the quantitative analysis of the quaternary mixture of ascorbic acid (AA), paracetamol (PAR), caffeine (CAF) and chlorpheniramine maleate (CPA) in a commercial dosage form. The developed UPLC-PDA method offered a new possibility for the co-determination of four active ingredients in a drug combination with short run time and simple sample preparation. The successful chromatographic separation of the four drugs was performed using a Waters Acquity UPLC BEH C18 column (1.7 µm 2.1 × 100 mm) (Mildford, USA) and a mobile phase consisting of water (12 %), acetonitrile (13 %) and 0.1 M H₃PO₄ (75 %) at a flow rate of 0.25 mL/min. The validation of the proposed UPLC-PDA approach was verified by analyzing synthetic mixtures, inter- and intra-day experiments, and commercial powder samples and provided satisfactory results.

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开发一种新型超高效液相色谱（UPLC）方法，用于共同预测多组分药物制剂中的四种活性化合物

本研究首次开发了一种基于光电二极管阵列检测（UPLC-PDA）的新型超高效液相色谱法，用于定量分析商品剂型中抗坏血酸（AA）、扑热息痛（PAR）、咖啡因（CAF）和马来酸氯苯那敏（CPA）的四元混合物。所开发的 UPLC-PDA 方法运行时间短、样品制备简单，为同时测定复方药物中的四种有效成分提供了新的可能。采用Waters Acquity UPLC BEH C18色谱柱（1.7 µm 2.1 × 100 mm）（美国米尔福德）和由水（12%）、乙腈（13%）和0.1 M H3PO4（75%）组成的流动相，流速为0.25 mL/min，成功地实现了四种药物的色谱分离。通过分析合成混合物、日间和日内实验以及商业粉末样品，验证了所建议的 UPLC-PDA 方法，并提供了令人满意的结果。

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来源期刊

Journal of Chromatography B 医学-分析化学

CiteScore

5.60

自引率

3.30%

发文量

306

审稿时长

44 days

期刊介绍： The Journal of Chromatography B publishes papers on developments in separation science relevant to biology and biomedical research including both fundamental advances and applications. Analytical techniques which may be considered include the various facets of chromatography, electrophoresis and related methods, affinity and immunoaffinity-based methodologies, hyphenated and other multi-dimensional techniques, and microanalytical approaches. The journal also considers articles reporting developments in sample preparation, detection techniques including mass spectrometry, and data handling and analysis. Developments related to preparative separations for the isolation and purification of components of biological systems may be published, including chromatographic and electrophoretic methods, affinity separations, field flow fractionation and other preparative approaches. Applications to the analysis of biological systems and samples will be considered when the analytical science contains a significant element of novelty, e.g. a new approach to the separation of a compound, novel combination of analytical techniques, or significantly improved analytical performance.